Valsartan is a widely-used prescription drug used to control hypertension and other heart issues. Earlier this year it was observed that some ingredients used to manufacture Valsartan were contaminated with NDMA. NDMA (N-nitrosodimethylamine) is known to cause cancer in humans. This data immediately motivated the FDA and European health agencies to create worldwide safety recalls of the contaminated Valsartan products. About Valsartan Valsartan is an antihypertensive drug that is taken for the treatment of high blood pressure as well as for people with congestive heart issues. It’s also prescribed to people with ventricle dysfunction after suffering a heart attack. Valsartan works by effectively blocking angiotensin II - a peptide hormone that causes constriction of the blood vessels promoting higher blood pressure. This functionality made Valsartan more effective than similar medications before it that merely worked by blocked the conversion of angiotensin I into angiotensin II (known as ACE inhibitor drugs).
Valsartan established itself to be very effective not only for patients with high blood pressure but additionally people with congestive heart failure. In a recent study, Valsartan was measured against Captopril and another ACE inhibitor after a heart attack. The study found that Valsartan was as effective as Captopril in keeping heart failure at bay.
An additional report found Valsartan reduced the risk of heart failure by some 20 percent compared to a placebo group. These results led the FDA to approve a label adjustment allowing Valsartan to be used by doctors for people with heart failure in addition to hypertension.
Valsartan was initially created by American pharmaceutical giant Novartis and it was registered for use by the FDA in 1996. It was made available under the brand name Diovan prior to losing patent protection and then sold as a generic medication as valsartan. Following its launch, Valsartan quickly became one of the most widely taken prescription drugs globally in the competitive blood pressure drug market. In 2010, just four years after its launch, worldwide sales for the medication exceeded $6 billion. When the original patent period for Valsartan expired in 2012 many other pharmaceutical companies began making generic variations of the drug. The largest generic manufacturers of Valsartan were Teva Pharmaceuticals Industries Ltd. and Solco Healthcare Inc. Contamination of Valsartan with NDMA In July 2018, one of the leading makers of generic valsartan, the Chinese manufacturer Zhejiang Huahai Pharmaceuticals, first discovered that the raw Valsartan it was producing was contaminated. Zhejiang Huahai is a wholesale pharmaceutical manufacturing lab that makes valsartan and distributes it through U.S. channels Prinston, Huahi and Solco. The company synthesizes the Valsartan compound then distributes it to major pharmaceutical companies around the world who then use it to make, package and market their own generic versions of Valsartan. Zhejiang Huahai was by far the biggest wholesale manufacturer of Valsartan component. During late June 2018, quality control tests at Zhejiang Huahai revealed that the batches of Valsartan it was manufacturing were dangerously contaminated with N-nitrosodimethylamine (NMDA). The appearance of NDMA was totally unexpected. The NDMA contamination was apparently caused by a change in the process of producing the medication that Zhejiang Huahai had chosen several years earlier.
The discovery raised significant safety issues because of the known dangers of NDMA. NDMA is a well-known leftover of certain chemical manufacturing processes. NDMA is classified as a carcinogen because it is known to cause cancer in humans. Numerous animal studies have proven that exposure or ingestion of even tiny amounts of NDMA can cause cancer in the liver, gastrointestinal system, and in the kidneys. At one time NDMA was used in the manufacture of rocket fuel, but this use was halted due to issues regarding environmental contamination. The EPA regards NDMA as a probable human carcinogen. NDMA is regarded as a priority toxic pollutant in federal regulations.
After uncovering the NDMA contamination, Zhejiang Huahai immediately notified pharmaceutical companies and safety officials. This prompted the U.S. Food and Drug Administration (FDA) and European health officials to immediately recall all possibly affected versions of Valsartan. Since that time, NDMA contamination has been discovered in the valsartan components made by 2 other pharmaceutical suppliers: Zhejiang Tianyu Pharmaceuticals of Taizhou, China; and Hetero Labs Ltd. in India. Lab testing on the components from these labs revealed lower amounts of NDMA compared to the Zhejiang Huahai product.
The most effective manner to underscore how dangerous the issue with these contaminated medications is to show that there is bipartisan support for further investigation in Congress. Congress can’t agree on the hue of the sky but they agree that they want additional data on what occurred with Valsartan. Potential Injuries from Contaminated Valsartan NDMA is not only a very dangerous carcinogen, but it can also be a poison at high levels. There has been many reported cases in which people died from internal bleeding and severe liver damage after ingesting high doses of NDMA on just one occasion. In animal testing, taking high to moderate amounts of NDMA caused major liver damage after only a few days and cancer after just a few months.
An investigation about the cause of the NDMA contamination has shown that it was probably caused by an alteration in the manufacturing process that Zhejiang Huahai began several years ago. This means that Valsartan tainted with NDMA was on the market for several years before observation and recall. This is extremely distressing because Valsartan is used as a maintenance medication which is taken daily on a continuing manner. This means that some people might have been ingesting NDMA once or twice a day for many years. This sort of continuous long-term ingestion is specifically the kind of exposure that might cause cancer. NDMA exposure is related to specific cancers like: Liver Cancer Gastric Cancer Colorectal Cancer Kidney Cancer
Given the global ingestion of Valsartan, the number of patients who might develop cancer from exposure to NDMA is extremely large.
What Valsartan Patients Need to Know If you have been taking Valsartan for treatment of hypertension or other issues, you can immediately meet with your prescribing physician regarding the possible dangers to your wellness. You should also determine what generic version of Valsartan you were getting from your pharmacy. Not every generic versions of Valsartan were contaminated with NDMA, though the list continues to grow as the research proceeds. In the United States the safety recall only applied to the Valsartan manufactured by Solco Healthcare, Teva Pharmaceutical, and Major Pharmaceuticals.
What Amount of Money Can You Expect from a Valsartan Settlement? Understandably, affected valsartan cancer would like to know what the possible settlement amount of the Valsartan case may be. It’s a valid question. The suffering users may experience is significant and money compensation is all we have to strive towards justice. The Valsartan lawsuits are simply too recent to gauge the potential settlement amount of these claims. We’ll understand more as the litigation progresses. A note to settlement value is to have lawyers that are going after every potential dollar and are fighting to maximize the amount of your case for everything that you have had to live with either as a victim or surviving family member.
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Author : Sargent Rodriguez |
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